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GxP Lifeline
  • 2022-bl-gxp-lifeline-supplier-audit_132x132

    Improving Quality Through Supplier Audits

    Supplier audits are the cleverly disguised exams of the manufacturing world. Suppliers and manufacturers are held to high quality standards and both must adhere to them to ensure final products are safe and effective. The key to this is a thorough supplier audit in which the supplier and manufacturer work together to improve quality throughout the supply chain.

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  • MasterControl’s latest infographic on Pharma  Manufacturing Trends

    Your Pharma Manufacturing City of the Future

    The future of pharma manufacturing is here, and companies are racing to stay up to speed with the latest industry trends. A new interactive infographic tests your knowledge of pharma manufacturing trends and illustrates the optimal pharma manufacturing operation.

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  • Digitizing your medical device manufacturing shop floor helps with EU and US regulation compliance.

    EU MDR vs. U.S. QSR and the Role of Digitization

    There are more similarities than differences in the ways medical devices are regulated in the U.S. versus their regulation in Europe. But those subtle differences are critical to understand if you plan to market devices in both regions. See how EU and U.S. medical device regulations compare and learn how digitization streamlines compliance in both regions.

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  • Benefits of adopting a modern MES solution by pharma manufacturing companies, featured by MasterControl.

    A Modern Pharma MES Solution Offers the Best of Old and New

    A manufacturing execution system (MES) solution should offer you the best pharma MES functionality in a simplified package to match your current and future manufacturing needs. Beyond that, it should also expand your visibility across critical pivot points throughout your manufacturing operation. Ultimately, it should support your organizational growth. This post discusses how a modern MES achieves these things.

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  • 3 steps to prepare Pharma CMOs and CDMOs meet supply continuity challenges.

    Maintaining Supply Continuity: 3 Ways to Ease Pharma CMO and CDMO Worries

    As we cope with the aftermath of COVID-19 in these uncertain times, it’s critical for pharma outsourcers to control the controllable aspects of supply continuity. These three practical steps will prepare pharma CMOs and CDMOs to handle the supply continuity challenges that will inevitably arise.

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  • MasterControl’s 6 Common Myths About Adopting a Manufacturing Execution System (MES) industry brief

    6 Common Barriers to Adopting a Traditional MES Solution

    For most production environments, the barriers to adopting a traditional manufacturing execution system (MES) have kept many organizations from digitizing and automating their manufacturing environment. However, new manufacturing technologies are providing smarter, faster, and more affordable paperless shop floor alternatives to legacy MES solutions.

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  • The alignment between the FDA’s ISO 13485 & 21 CFR Part 820 featured by quality management experts, MasterControl

    Bringing ISO 13485 to 21 CFR Part 820

    For years now, the FDA has observed that ISO 13485 and 21 CFR Part 820 have a great deal in common and largely accomplish the same level of quality assurance. Now the FDA’s working on harmonizing them.

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  • 3 Foundational Principles of Quality 4.0 featured by quality management experts, MasterControl

    3 Characteristics of Successful Quality 4.0 Initiatives

    Intelligent, connected technologies are transforming the way life sciences companies manufacture and ensure the quality of their products. To stay competitive, companies are taking advantage of advanced tools and new technology-enhanced approaches to quality management. Leveraging the new solutions and enhanced levels of connectivity now available requires that you first understand three foundational principles of fruitful Quality 4.0 initiatives.

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  • Medical Device DHF 21 CFR 820 Compliance

    Alleviating Headaches From 21 CFR 820 Design Control Compliance

    Compliant medical device design is governed by federal regulations along with competitive market needs. The essential aspects of a design control subsystem are outlined here, along with the most strenuous tasks related to design control, including design reviews. Converting from paper or hybrid quality management systems to an automated one can further reduce the challenges related to managing the Design History File (DHF) and help you to be ready for FDA inspections at any time.

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  • MasterControl’s ”Simplify your CAPA Process in 7 Steps” industry brief

    The CAPA Process Magnificent Seven

    Learn about seven ways to simplify your CAPA process by taking a closer look at the 1960s classic “The Magnificent Seven.”

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  • The relation between your OCM strategy and your eQMS success

    OCM and eQMS: Transformation or Conformance?

    The digitalization of quality processes can bring transformative change to an organization, but doing it right requires a sound strategy. Learn the four steps that form the foundation of a good organizational change management (OCM) plan.

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  • How a digital EQMS helps the pharmaceutical manufacturing industry overcome challenges.

    How Modern eQMS Solutions Are Powering Pharma’s Digital Revolution

    The increasing complexity, diversity, and personalization of pharmaceutical products has prompted companies throughout the industry to reevaluate their quality approaches. Discover how digital EQMS innovations are enabling leaders to overcome modern challenges.

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  • Collect, connect, and contextualize medical device manufacturing data through advanced technologies to leverage digitization.

    Medical Device Manufacturing Trends, Pt. 2: Digitize to Make Data Usable

    As the move toward digitizing manufacturing has accelerated, so has usage of the advanced technologies underlying digitization. Some of the most significant shifts include increases in cloud migration and use of advanced technologies in manufacturing operations to leverage digitization and better collect, connect, and contextualize data.

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  • 6 Data Integrity Questions to follow FDA Guidance for Pharma companies

    FDA Guidance Assists With Preventing Data Integrity Violations

    The U.S. Food and Drug Administration (FDA) has long emphasized the importance of the data integrity aspect of current good manufacturing practices (CGMP). Hoping to reduce data integrity violations, the agency drafted a question-and-answer-based guidance to clarify data integrity guidelines.

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  • A man explaining the difference between Quality Assurance, Quality Control and EQMS to a woman.

    The EQMS for Your Quality Assurance and Quality Control Systems

    Quality is an important part of doing business in regulatory environments. Enabling both quality control and quality assurance in an organization is vital. Learn how QA and QC play into quality management and how an enterprise quality management system simplifies them.

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  • Ensure QMS Compliance

    6 Ways to Ensure Your Quality Management System Meets FDA and ISO Compliance

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Following these six guidelines will help FDA-regulated and ISO-certified organizations optimize their QMS to ensure high-quality products and continuous compliance.

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  • How pharma companies avoid CAPA chaos and compliance issues with MasterControl’s smart CAPA management system.

    CAPA Overload and Other Perils to Avoid on Your Compliance Journey

    Managing corrective actions/preventive actions becomes overly burdensome for pharma companies when quality problems are escalated to CAPA regardless of their impact or scope. Learn a smarter approach that can help your organization avoid CAPA chaos and other obstacles you’ll face along the road to compliance.

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  • How to Improve decision making in your Quality Trend Analysis efforts.

    Trend Analysis on Quality Management: Improving Decision-Making With Timely Data

    You can’t make quality improvements without accurate, current, and meaningful data. But getting access to better process and performance data may require a different approach to quality trend analysis. Learn the answers to three critical questions about trend analysis in quality management.

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  • MasterControl’s computer system validation to maintain FDA compliance.

    5 Answers to FDA Computer System Validation Questions

    Computer system validation can drag on for months. However, it doesn’t have to. The FDA has indicated that a risk-based approach would reduce the validation burden while maintaining compliance.

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  • How to implement a Digital QMS with Quality 4.0 Principles

    OCM and a Digital QMS: Your Combination for a Competitive Edge

    Digitization enables companies to completely transform their quality processes, but simply going digital is only half the equation. Nancie Celini shows the importance of applying organizational change management and Quality 4.0 principles when implementing a digital QMS.

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